Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00824551
Status:
UNKNOWN
Last Update Posted:
2009-01-16
First Post:
2009-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2009-01-15', 'studyFirstSubmitDate': '2009-01-15', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burns conversion', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Bacteriology culture and immunology markers', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Thermal Burns', 'Hyperbaric Oxygen Therapy', 'Burns conversion'], 'conditions': ['Acute Thermal Burns']}, 'descriptionModule': {'briefSummary': 'The blinded RCTstudy aims to:\n\n* Determine the effects of HBOT on burns conversion for patients who have fresh thermal burns injury using the LDI.\n* Objectively determine the proportion of burns conversion in areas of partial thickness burns for early thermal burns injury in both arms of the RCT.\n* Study the effects of HBOT on immunological markers IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α and TGF-β ( comparison between both arms and 2 assessment points).\n* Study the effect of HBOT on haematological markers including procalcitonin ,albumin, lymphocyte counts, neutrophil count, and macrophage count.\n* Study the effects of HBOT on histology specimens in quantifying P53 protein, leukocyte and macrophage infiltration, burns depth assessment and vascular endothelial growth factor (VEGF) and inducible nitric oxide synthase (iNOS) .\n* Study the effects of HBOT on bacteriology of tissue culture in areas of deep dermal burns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thermal burns injury less than 40% with areas of deep dermal/ full thickness burns.\n* Less than 24 hours from time of injury.\n* No inhalational injury (Nasoendoscopy and bronchoscopic diagnosis by burns centre medical team/ department of emergency medicine in SGH).\n* Age 21 years old and above and less than 60 years old.\n* Not intubated and not on inotropic support.\n* Understands and agrees to informed consent (approved by IRB SGH).\n\nExclusion Criteria:\n\n* Untreated pneumothorax\n* Medications: Bleomycin, Cis-platin, Doxorubicin, Disulfiram (Chemotherapy)\n* Acute uncontrolled medical condition or significant medical condition (eg. Cerebrovascular accident, diabetic ketoacidosis, severe hypertensive 180/ 110 mmHg, end stage renal failure, chest pain, bleeding gastrointestinal tract, coma and acute asthma attack)\n* Other surgical emergencies (eg. open fractures, compartment syndrome and acute abdomen)'}, 'identificationModule': {'nctId': 'NCT00824551', 'briefTitle': 'The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns', 'orgStudyIdInfo': {'id': '1501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric Oxygen Therapy', 'description': '2 HBOT treatments', 'interventionNames': ['Procedure: Hyperbaric Oxygen Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Standard care and treatment', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy', 'type': 'PROCEDURE', 'description': '2 sessions of HBOT ( HDMC 14)', 'armGroupLabels': ['Hyperbaric Oxygen Therapy']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Patient will undergo standard care', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'chong si jack, mbbs,m.med', 'role': 'CONTACT', 'email': 'chong_si_jack@hotmail.com', 'phone': '65-91467592'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'chong si jack', 'role': 'CONTACT', 'email': 'chong_si_jack@hotmail.com', 'phone': '65-91467592'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'chong si jack', 'oldOrganization': 'republic of singapore navy and singapore general hospital'}}}}